Z-2645-2017Class II

Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites...

Name: Z-2645-2017 Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites...
Creator: Boston Scientific Corporation
Published: 2016-12-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-12-15 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer... on 2016-12-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2645-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-15
Posted: 2017-06-27
Terminated: 2018-04-10
Recalling firm: Boston Scientific Corporation
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)
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: 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 tag: manufacturing process
FDA root cause: Employee error
Action: 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 [email protected]
Quantity in commerce: 39 boxes of 5 (195 units)
Distribution: CA, FL, KY, MO, NM, OK, OR, PA, and TX.
Product codes and lots: Lot: 00112758, Use by 2018-05-11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2645-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2645-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-06-30

Product code DQO

K121694Class IIImager II Angiographic CatheterBoston Scientific Corp / cleared 2012-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)