Z-2074-2012Class II

BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only...

Name: Z-2074-2012 BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only...
Creator: Bridgepoint Medical
Published: 2012-06-26
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2012-06-26 / Terminated / root cause: manufacturing process

FDA source

Bridgepoint Medical began a recall of BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th... on 2012-06-26. FDA classified it as Class II and gives the reason as "BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of...". 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-2074-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-26
Posted: 2012-07-24
Terminated: 2012-09-06
Recalling firm: Boston Scientific Corporation
Product: BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
Product code: DQY Catheter, Percutaneous
Reason for recall: BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal. In no case was there any reported adverse clinical event related to the problem.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, BridgePoint Medical, sent an "Urgent Field Safety Notice" letter dated June 26, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory, quarantine the affected lots and complete and return the enclosed "Verification Form" via fax to 763-225-8718 ,attn: BridgePoint Medical, Inc., Upon receipt of form, BridgePoint will supply the customers with the appropriate materials to return the products. If you have any questions regarding this notice, please call BridgePoint Medical, Vice President of Quality Assurance, at 763-225-8511 or e-mail at [email protected].
Quantity in commerce: 95 (57 USA, 38 OUS)
Distribution: Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden.
Product codes and lots: Lots affected in US: BP20121440078, BP20121560089 Lots affected OUS: BP20121510086, BP20121500080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2074-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2074-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-24

Product code DQY

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)