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Cardioblate CryoFlex recallZ-0494-2021 · Medtronic Ats Medical, Inc. · initiated Oct 12, 2020

Terminated

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Medtronic Ats Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

FDA root cause category: Under Investigation by firm

What the company is doing

In the United States (US), beginning 29-Oct-2020, a written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification. The letter requests the following actions: - Identify and quarantine all unused CryoFlex Surgical Ablation devices as listed in the table below. - Return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-854-3570 to initiate a product return. Your local Medtronic Representative can assist you in the return of this product. - < Please complete the enclosed Customer Confirmation Form and email to [email protected]. > - Please forward this notice to all those who need to be aware within your organization.

Recall details

Recall number
Z-0494-2021
Status
Terminated
Initiated by the company
Oct 12, 2020
Recalling firm
Medtronic Ats Medical, Inc.
Quantity
57 units
Product code
OCL
FDA submissions
K123733
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

Product description

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

Code information (models, lots, serial numbers)

Model Number 60SF3, GTIN 00763000114626 Serial Numbers: 17420000, 17420001, 17420002, 17420003, 17420004, 17420005, 17420006, 17420007, 17420008, 17420009, 17420010, 17420013, 17420014, 17420015, 17420016, 17420017, 17420018, 17420019, 17420020, 17420022, 17420023, 17420024, 17420025, 17420026, 17420027, 17420028, 17420029, 18420000, 18420001, 18420002, 18420003, 18420004, 18420015, 18420016, 18420021, 18420022, 18420023, 18420024, 18420025, 18420026, 18420027, 19820016, 19820017, 19820018, 19820019, 19820020, 19820021, 19820022, 19820023, 19820024, 21020005, 22320038, 22320040, 22320041, 22320042, 22320043, 22320044

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K123733 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 86666).

Sources and updates

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