7F Freezor Cardiac Cryoablation catheter, REF # 207F1.… recallZ-1452-06 · CryoCath Technologies Inc. · initiated Aug 4, 2006
Terminated All recalls posted in August 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CryoCath Technologies Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
Consignees were notified by letter on 08/04/2006.
Recall details
- Recall number
- Z-1452-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 4, 2006
- Posted by the FDA
- Aug 29, 2006
- Recalling firm
- CryoCath Technologies Inc.
- Quantity
- 34 units
- Product code
- LPB
- FDA submissions
- P020045
- Distribution
- Nationwide, including AZ, CA, CO, CT, DE, FL, GA, KY, MD, MI, NE, NY, OH, PA, TX.
Product description
7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
Code information (models, lots, serial numbers)
Reference # 207F1, Lot number 00418.
Other devices under the same FDA submission
25 devices cleared under P020045 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- N/A 2035UMedtronic, Inc. · Cardiac ablation percutaneous catheter1 recall1 report
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter41 reports
- NA 106A3Medtronic CryoCath LP · Cardiac ablation percutaneous catheter19 reports
- NA 106A3Medtronic CryoCath LP · Cardiac ablation percutaneous catheter18 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter14 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter11 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter10 reports
- Freezor™ Xtra 217F3Medtronic, Inc. · Cardiac ablation percutaneous catheter7 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter6 reports
- NA 2035UCMedtronic, Inc. · Cardiac ablation percutaneous catheter6 reports
- NA 106A3Medtronic, Inc. · Cardiac ablation percutaneous catheter5 reports
- NA 106A3Medtronic CryoCath LP · Cardiac ablation percutaneous catheter4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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