Z-0071-2012

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

Name: Z-0071-2012 ***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing...
Creator: Cardiocommand Inc.
Published: 2010-10-25
License: https://open.fda.gov/license/

Cardiocommand Inc. / initiated 2010-10-25 / Terminated / root cause: manufacturing process

FDA source

Cardiocommand Inc. began a recall of ***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series... on 2010-10-25. The reason FDA records is "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". 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-0071-2012
Status: Terminated
Initiated: 2010-10-25
Posted: 2011-10-19
Terminated: 2012-08-28
Recalling firm: Cardiocommand Inc.
Product: ***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.cardiocommand.com. ***REF #200-0010***TAPSCOPE 550 CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400155-B 091101. ***REF #200-0025***TAPSCOPE 550 Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. ***LOT xxxxxxx***FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: Tampa, FL USA 33607. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. 400215-A 100902.
Product code: LPA System, Esophageal Pacing
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 567 total
Distribution: Nationwide Distribution -- GA, OR, TX, CO, KY, MT, MA, AL, CA, FL & TN.
Product codes and lots: Lot Numbers: 1026504, 1023803, 1022901, 1019007, and 1020106.

Product code LPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)