Z-1452-06

7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc

Name: Z-1452-06 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc
Creator: CryoCath Technologies Inc.
Published: 2006-08-04
License: https://open.fda.gov/license/

Medtronic CryoCath LP / initiated 2006-08-04 / Terminated / root cause: labeling and UDI

FDA source

CryoCath Technologies Inc. began a recall of 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc on 2006-08-04. The reason FDA records is "Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1452-06
Status: Terminated
Initiated: 2006-08-04
Posted: 2006-08-29
Terminated: 2007-01-16
Recalling firm: Medtronic CryoCath LP
Product: 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
Product code: LPB Cardiac Ablation Percutaneous Catheter
Reason for recall: Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by letter on 08/04/2006.
Quantity in commerce: 34 units
Distribution: Nationwide, including AZ, CA, CO, CT, DE, FL, GA, KY, MD, MI, NE, NY, OH, PA, TX.
Product codes and lots: Reference # 207F1, Lot number 00418.

Product code LPB

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)