—#154140

Product

Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K121694
Affected lot / code info: Lot: 00112758, Use by 2018-05-11

Why it was recalled

A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.

Root cause (FDA determination)

Employee error

Action the firm took

Customers were sent an Urgent Medical Device Removal letter, dated 12/15/2016, via overnight mail delivery beginning 12/15/2016. The letter identified affected product, described the issue, and asked for product to be returned. Removal instructions were provided and a Reply Verification Tracking Form was asked to be returned. Questions can be directed to Nicole Pshon, Field Action Manager at 763-494-1133 or BSCFieldActionCenter@bsci.com

Recalling firm

Firm: Boston Scientific Corporation
Address: 2 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: CA, FL, KY, MO, NM, OK, OR, PA, and TX.

Timeline

Recall initiated: 2016-12-15
Posted by FDA: 2017-06-27
Terminated: 2018-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154140. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.