Bridgepoint Medical: Medical Device Recall in 2012 - (Recall #: Z-2074-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 26, 2012

Date Posted: August 1, 2012

Recall Number: Z-2074-2012

Event ID: 62450

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.

Status: Terminated

Product Quantity: 95 (57 USA, 38 OUS)

Code Information:

Lots affected in US: BP20121440078, BP20121560089 Lots affected OUS: BP20121510086, BP20121500080

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated