Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL… — Class II medical device recall Z-1336-2015
Terminated recall by Boston Scientific Corporation, reported 2015-04-08, distributed in CA, FL, IL, LA, MD, NY, OH, WI. Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Cathe
| Recall number | Z-1336-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2015-02-25 |
| Classified | 2015-03-27 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2016-08-12 |
| Distributed | CA, FL, IL, LA, MD, NY, OH, WI |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FI, FR, GB, HU, IT, NL, PT |
| Quantity | 918 |
| Lot numbers | 17228343, 17244079, 17245000, 17245001, 17245002, 17259556, 17259557, 17259558, 17259581, 17259582, 17259584, 17275816, 17275817, 17275818, 17275820, 17275823, 17297984, 17297985, 17297986, 17317546, 17317825, 17318044, 17328800, 17328801, 17328810, 17338203, 17338205, 17352479, 17353160, 17362834, 17362835, 17365681, 17365682, 17365683, 17365684, 17370706, 17370708, 17376747, 17376748, 17377392 and 91 more |
Product
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.
Reason for recall
Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after an Expel" APD catheter was implanted in the biliary system. The most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive meth
Machine access
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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.