{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "43212", "product_res_number": "Z-0409-06", "event_date_initiated": "2005-12-07", "event_date_posted": "2006-01-31", "recall_status": "Terminated", "event_date_terminated": "2007-08-07", "res_event_number": "34163", "product_code": "MCX", "k_numbers": [ "K052038" ], "pma_numbers": [ "P950020" ], "product_description": "The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades)\nmounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as AtherotomyQ3J, allows dilatation of the target lesion with less pressure. The device is provided in 6 mm, 10 mm, and 15 mm lengths. The working length is the distance between the radiopaque marker bands. The proximal catheter shaft of the Flextome Cutting Balloon Device is a hypotube. This hypotube contains the inflation lumen for the balloon. The distal shaft is made of flexible material and contains two lumens. One lumen is for balloon inflation, and the second lumen is a guidewire lumen. The distal shaft is coated with a hydrophilic coating. The guidewire lumen is colored green for greater visibility. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchanges. A needle with a luer port is included for flushing the wire lumen prior to the insertion of appropriate coronary guide wires. CLlPIT1M clips are provided to aid in handling of the catheter.", "code_info": "Lot/Batch# EF0341  EF0349  EF0350   EF0354 EF5047  EF5048  EF5093   EF5098  EF51 05  EF5168  EF5169  EF5170  EF5390  EF5396 EF5398  EF5404   EF5574  EE0914E  EF5046  EF5068  EF5198  EF5329 EF5562 EE0885E   EE0939E  EF0411  EF0429  EF5050  EF5051  EF5056  EF5095  EF5194  EF5273  EF5285  EF5341  EF5478  EF5566  EF5566''  EE0916E  EF5007  EF5086  EF5391  EE0937E  EF0351  EF5096  EF5235 EF5567 EE0915E   EF5067  EE0943E  EF5230  EF0213  EF5101  EF5172  EF5236  EF5573  EF0342  EF5217  EF5403  EE0924E  EF5102  EF5242  EF5296  EF5479  EE0932E  EF5286  EE0933E EF5209  EF5392  EFO028E  EF5004 EF5091  I\t \tEF5229 \t EF5291 \t EF5564 \t EF0339 \t EF5222 \t EF5261 \t EF5397 \t EE0880E  \t EF0340 \t EF0343 \t EF0419 \t EF5092 \t EF5097 \t EF5100 \t EF51 04 \t EF5195 EF5243  EF5280  EF5287  EF5315  \t EF5331 \t EF5476 \t EF5485 EF5537  EF5563  \t EF0348 \t EF0353 \t EF5006 \t EF5171 \t EF5197  \t EF5314 \t EF5389 \t EF5497 \t EF5575 \t EF5368 \t EF5383 \t EF5363 \t EF5402 \t EF5379 \t EF5386 \t EF5387 \t EF5409 \t EF5401 \t EF5384 \t EF5571 \t EE0940E \t EF5008 EF5282  EE0904E  EF0370  EF5049  EF5200   EF5272  EF5292  EF0345  EF5099  EF0204  EF5050  EF5267  EF5294  EE0917E  EF5293  EE0906E  EF5196  EF5388  EF5360  EF5385  EF5361  EF5588  EF5589  EFO057 EFO097  EF5109  EF5311  EF5481  EF5556  EFO033  EFO067  EF0150  EF0167  EF0407  EF5015  EF5020  EF5063  EF5110  EF5149  EF5249  EF5446  EF5461  EF5462  EF5551  EF5561  EF5615  EF0202  EF0315 EF0316\t \t EF0317\t \t EF0426\t \t \t EF5073\t \t EF5122\t \t EF5441\t \t EF5460\t \t EF5501\t \t EF5550\t \t EF5586\t \t EF5607\t \t \t EFO041\t \t \t EFO056\t \t EFO078\t \t EF0147\t \t EF0163\t \t EF0166\t \t EF0193\t \t EF0304\t \t EF0319\t \t EF0320\t \t EF0409\t \t EF5014\t \t EF5016\t EF5025  EF5114  EF5123  EF5139  EF5144  EF5145  EF5151  EF5183  EF5299  EF5300  EF5301  EF5302  EF5312  EF0208  EF5021  EF5023   EF5024  EF5027  EF5031  EF5037  EF5058  EF5065  EF5115  EF5132 EF5140  EF5585  EFO059  EFO068  EFOO77  EFO080  EFO095  EF0152  EF0162  EF0165  EF0201  EF0207  EF0305  EF0406   EF5022   EF5041   EF5060  EF5070  EF5085  EF5124   EF5125  EF5126  EF5127  EF5130 EF5147 \t EF5157 \t EF5158 \t EF5178 \t EF5185 \t EF5238 \t EF5248 \t EFO058 \t EFO069 \t EF0107 \t EF0158 \t EF0301 \t EF5083 \t EF5089 \t EF5116 \t EF5131 \t EF5146 \t EF5557 \t EE0881 E \t EFO074 \t EF0127 \t \t EF0128 \t \t EF0129 \t EF0131 EF0132\t\t\t \t\t\t EF0155\t\t\t \t\t\t EF0168\t\t\t \t\t\t EF5084\t\t\t \t\t\t EF5090\t\t\t \t\t\t EF5159\t\t\t \t\t\t EF5179\t\t\t \t\t\t EF5221\t\t\t \t\t\t EF5241\t\t\t \t\t\t EF5250\t\t\t \t\t\t EF5558\t\t\t \t\t\t EFOO08\t\t\t \t\t\t EF0187\t\t\t \t\t\t EF0323\t\t\t \t\t\t EF5044\t\t\t \t\t\t EF5045\t\t\t \t\t\t EF5057\t\t\t \t\t\t EF5121\t\t\t \t\t\t EF5447\t\t\t \t\t\t EF5500\t\t\t \t\t\t EF5502\t\t\t \t\t\t EF5606\t\t\t \t\t\t EF01 06\t\t\t \t\t\t EF0395\t EF0424  EF5119  EF5150  EF5448  EF5498  EF5540  EF5580  EF0192  EF0199  EF0303  EF0396  EF0397  EF0398  EF5029  EF5035  EF5052  EF5088  EF5120  EF5141  EF5155  EF5156  EFO079  EF0157  EF0186 EF5079  EF5134  EF5451   EF5499  EF5541   EFOO09  RB43  EF0198   EF0302   EF5013  EF5017   EF5053    EF5059    EF5076    EF5148   EF5152    EF5310  EF5450   EF5503    EFOO07    EF0185    EF0292    EF5237    EF5452    EF5470 EF5548  \t EF0161  \t EF0322  \t EF5039 \t EF5080 \t EF5111 \t EF5440 \t EF5506 \t EF5549 \t EFO081 \t EF0299 \t EF5018 \t EF5465 EF5504  \t EF5555 \t EFO075 \t EFO093 \t EFO098 \t EF0115 \t EF0149 \t EF0151 \t EF0205 \t \t EF5087 \t EF5240 EF5251  EFO018\n EFO094  EF5077  EF5420  EF5469  EF5519  EFO066  EF0105  EF0368  EF0379  EF5072  EF5078  EF5081  EF5112  EF5463  EF0428  EF5192  EF5262  EE0925E  EF5207  EF5263  EE0934E  EF0360 EF5094 \t \t EF5208 \t EF527 4 \t EF5279 \t EF5477 \t EF5565 EE0941 E  \t EF5005 \t EF5193 \t EF5265 \t EF5496 \t EF0352 \t EF0369 \t EF5103 \t EF5106 \t EF5216 \t EF5330 \t EF5486 \t EF5572 \t EFO017 \t EFO032 \t EF0114 \t EF0117 \t EF0321 EF5422  EF5521  EF5527  EFO016  EF0104 EF0116  EF0124  EF0148  EF0189  EF0365  EF0366  EF5107 EF5135  EF5532  EF5553  EFO052  EF0159  EF0296  CBM335015  EF0297  EF5074  EF5082  EF5464  EF5480  EF5505 EF5584  EF0408  EF0410  EF5061  EF5075  EF5475  EF5533 EF5587  EFO030   EF5033  EF5064  EF5108  EF5219  EF5220  EF5254  EF5449  EF5552  EF5599  EFO082  EF0421  EF5239  EF5252  EF5442  EF5518 EFO031  EF0156", "firm_fei_number": "2024805", "recalling_firm": "Boston Scientific Corporation", "address_1": "3574 Ruffin Rd", "city": "San Diego", "state": "CA", "postal_code": "92123-2597", "additional_info_contact": "Abe Mathews\n408-895-3981", "reason_for_recall": "The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.", "root_cause_description": "Other", "action": "All affected direct accounts will be given notification by Overnight mail 1/26/2006. 100% of the total number of customers are to be contacted.", "product_quantity": "qty in US:25,311", "distribution_pattern": "Nationwide plus Argentina Austria Belgium Brunei\nCanada\nChile\nChina Colombia Czech Republic Denmark Finland\nFrance Germany Great Britain Hong Kong Hungary\nIndia Indonesia Ireland\nIsrael\nItaly\nLatvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. Singapore South Africa Spain\nSweden Switzerland & Turkey", "openfda": { "device_name": "Catheter, Coronary, Atherectomy", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "pma_number": [ "P130005", "P980037", "P900056", "P910019", "P890043" ], "registration_number": [ "1000121056", "1225687", "3002631703", "2134265", "3010220595", "3002807314", "2183744", "1643817", "3004091615", "9681260", "2133810", "3010273872", "3011120183", "3021632375", "3008814558", "3007695959", "2126666", "2124215", "3014479313", "3000279201", "3004742232", "3003708554", "2648729", "9616684" ], "fei_number": [ "1000121056", "3002631703", "3002095335", "3010220595", "3002807314", "3001451463", "2183744", "1643817", "3004091615", "3002913962", "3010273872", "3011120183", "3021632375", "3008814558", "3007695959", "3000203066", "2126666", "2124215", "3014479313", "3000279201", "3004742232", "3003708554", "3002806565", "2648729" ] } } ] }