FDA Device recall Z-1336-2015
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Cath…
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Cath… by Boston Scientific, citing 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 devic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1336-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-25 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | CA, FL, IL, LA, MD, NY, OH, WI |
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
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
Identifiers
| code_info | UPN # LOT # H7493931006200- 17259582, 17362835, 17501623, 17617274. H…UPN # LOT # H7493931006200- 17259582, 17362835, 17501623, 17617274. H7493931008200- 17259557, 17297984, 17362834, 17376747. H7493931010200- 17318044, 17376748, 17459140, 17501573, 17617545. H7493931012250- 17275816, 17501620, 17575123, 17617353. H7493931014250- 17370708, 17604432, 17624928. H7493931106150- 17259581, 17365684, 17617551. H7493931108150- 17244079, 17404400, 17408751, 17493552, 17647113 H7493931108250- 17245000, 17275820, 17297985, 17297986, 17377401, 17416602, 17433865. H749393110825K1- 17416577. H7493931108450- 17245001, 17408755, 17411332, 17493550. H7493931110150- 17317825, 17518149. H7493931110250- 17228343, 17259558, 17317546, 17338203, 17365681, 17416573, 17438002, 17518150, 17588842, 17588844, 17621339, 17634403, 17634404, 17639037. H749393111025K1- 17328810, 17403872, 17416575, 17494061. H7493931110450- 17275823, 17416603, 17459143, 17617552. H7493931112250- 17259584, 17275818, 17338205, 1736 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1336-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.