Boston Scientific Fetch 2 Aspiration Catheter — Class I medical device recall Z-1342-2016
Terminated recall by Boston Scientific Corporation, reported 2016-04-27, distributed nationwide. Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from
| Recall number | Z-1342-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2016-03-22 |
| Classified | 2016-04-18 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2017-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, CA, CL, CY, DE, EC, ES, FR, GB, HR, HU, IT, JO, JP, KR, MX, MY, NL, PH, PT, SE, TH, TT, UY, ZA |
| Quantity | 21,155 units |
| Lot numbers | 129496, 130473, 139577, 141089, 141570, 142212, 145520, 145783, 148859, 149263, 153368, 153847, 154650, 154786, 154901, 155010, 155675, 155908, 156690, 156822, 158009, 158494, 158598, 158949, 159368, 159902, 160530, 160734, 161209, 161256, 162814, 162893, 162943, 163987, 164148, 166281, 166646, 168472, 169484, 169638 and 348 more |
| Model numbers | 109400-001 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1342-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.