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Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 A...

FDA Device Recall #Z-1342-2016 — Class I — March 22, 2016

Recall Summary

Recall Number Z-1342-2016
Classification Class I — Serious risk
Date Initiated March 22, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Boston Scientific Corporation
Location Maple Grove, MN
Product Type Devices
Quantity 21,155 units

Product Description

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

Reason for Recall

Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.

Distribution Pattern

Worldwide Distribution - US (nationwide) including DC & VI except DE, ID, SD, and WY and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Chile, Croatia, Cyprus, Ecuador, France, Germany, Great Britain, Hungary, Italy, Japan, Jordan, Korea, Malaysia, Mauritius, Mexico, Netherlands, Philippines, Portugal, South Africa, Spain, Sweden, Thailand, Trinidad, Tobago, and Uruguay.

Lot / Code Information

BATCH 129496 130473 139577 141089 141570 142212 145520 145783 148859 149263 153368 153847 154650 154786 155675 155908 156690 156822 158009 158494 158598 159368 159902 160530 161209 162814 162893 162943 163987 164148 166281 166646 168472 169484 169638 170169 170464 170471 171178 171385 171800 172254 172375 172518 172831 173151 173398 173897 173902 174153 174431 174617 174619 174721 174722 174727 174728 174804 174805 175189 175190 175782 175783 176048 176221 176385 176437 176438 176843 177414 177415 177970 177971 178252 178253 178254 178764 178848 178849 178894 178935 178936 180305 180306 180367 180368 180370 180747 181168 181169 181285 181933 181934 182257 182258 182259 182927 183220 183221 183451 183452 183539 183540 183974 184091 184092 184093 184244 184245 184478 184479 184531 184532 184633 184634 185180 185182 185354 185355 185395 185396 185397 185632 185633 185958 185959 185960 186145 186146 186147 186148 186149 186150 186151 186152 186153 186154 186326 186338 186498 186553 186554 186555 186556 186557 186558 186559 186732 186733 186765 186766 186767 186768 186769 186839 186876 186877 186938 186939 186940 187157 187158 187238 187239 187778 187779 187811 187812 188206 188207 188208 188758 188759 189082 189230 189231 189232 189233 189234 189235 189236 189237 189238 189239 189240 189241 189242 189243 189244 189245 189273 189274 189374 191401 191402 191403 191404 191405 191406 191407 191408 191409 191802 191803 192256 192257 192355 192356 192466 192467 192468 192469 192470 192471 192483 192484 192485 192486 192777 192778 192779 192780 192784 192785 192786 192914 192915 192916 192917 192918 192919 192921 192922 192923 192925 192926 192927 192928 192929 192930 192931 192932 192933 193146 193147 193148 193149 193150 193151 193152 193153 193154 193155 193156 193158 193159 193160 193161 193162 193356 193357 193358 193360 193361 193362 193363 193364 193449 193450 193451 193952 193953 193954 193955 193956 193957 193958 193959 193960 193961 193962 193963 193964 193965 193966 193967 193968 193969 193970 18737680 18760027 18760028 18844376 18881248 18939879 154901 155010 158949 160734 161256 172256 174316 174358 174381 174382 174383 176146 176324 176441 176442 176473 180748 180841 180842 180843 181497 181498 182438 182439 182923 182925 183830 183977 183978 185398 185644 186329 186330 186331 186332 186333 186334 186335 189612 189613 192478 192479 192480 192481 192482 193972 171807 171869 174834 178152 180301 181688 185645 186327 187539 190073 193444 176327 186144 186328 186734 188803 188804 188805 188806 188807 188808 188809 188810 188811 188812 188813 188814 188815 188816 188817 187150 187505 187509 187510 190463 190464 190465 190466 190982 190983 190984 192781 192782 192783 193447 193973 194039

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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