CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

Imager II Angiographic Catheter recalled by Boston Scientific

Boston Scientific is recalling Imager II Angiographic Catheter, M001316581 outer package UPN), M001316580, single unit, distributed in 8 states. The recall was initiated on 13 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 00116127, Expiration Date: September 30, 2018

Quantity recalled26 boxes of 5 (130 singles)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1781-2017
FDA event ID: 76002
Recalling firm: Boston Scientific, Maple Grove, MN
Classification: Class II
Status: Terminated
Recall initiated: 13 Dec 2016
FDA classified: 11 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

13 Dec 2016	Recall initiated by company
11 Apr 2017	Classified by FDA	+119 days
19 Apr 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.

Product as listed by the FDA

Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)

Where it was distributed

AZ, FL, MO, NJ, NY, OH, PA, and TX.

Arizona Florida Missouri New Jersey New York Ohio Pennsylvania Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot: 00116127, Expiration Date: September 30, 2018

Where was it sold?

AZ, FL, MO, NJ, NY, OH, PA, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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