Reported Apr 8, 2015 · Terminated
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit,…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Boston ScientificExpel" 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
- Lot codes and dates
- 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, 17365682, 17601584, 17613485, 17639463. H7493931112450- 17245002, 17259556, 17365683, 17416604, 17574538, 17617553. H7493931114250- 17370706, 17588840, 17625218. H7493931114450- 17275817, 17589950, 17624789. H7493932016300- 17328801, 17352479, 17377392, 17408752, 17501571, 17575124, 17612692, 17613484, 17625883, 17626180, 17626181, 17626182. H7493932018300- 17377395, 17480649, 17614751, 17617350, 17626183. H7493932024400- 17459142, 17492863. H7493932026400- 17328800, 17353160, 17377393, 17617470, 17624927, 17625216, 17625895.
- Amount recalled
- 918
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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