***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recordi

FDA device recall Z-0071-2012 · posted 2011-10-19 · Terminated

Recall details

Recalling firm

Cardiocommand Inc.

Reason for recall

CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ECG.

Action taken

On October 25, 2010, an Urgent Medical Device Recall Notice was sent by certified mail to all facilities advising them of the recall. The letter identified the affected product and reason for the recall. Users were asked to discontinue use and return the affected product to the firm. If all product was already used, then this should be indicated on the form provided. The firm will send replacement product in quantities equal to the returned product. The attached form should be completed and returned via fax. Customers were instructed to report any suspected incidents related to this issue to CardioCommand Customer Service at 1-800-231-6370. Also questions or comments should be directed to CardioCommand Customer Service.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LPA

Quantity affected

567 total

Distribution

Nationwide Distribution -- GA, OR, TX, CO, KY, MT, MA, AL, CA, FL & TN.

Date initiated

2010-10-25

Date posted

2011-10-19

Date terminated

2012-08-28

Location

Tampa, FL