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Terminated

CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

FDA Recall Z-1513-2015 · Posted 2015-04-23

Recalling FirmCSA Medical
Recall StatusTerminated
Product CodeGEH
Date Initiated2015-03-25
Date Terminated2015-08-21
Product Quantity82 units

Reason for Recall

TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax

Firm Action

CSA Medical issued letter dated 3/25/15 advising users of the problem. Users provided with: The mitigations available to the active venting procedures coupled with the extremely unlikely probability of injury, rare risk, thus allowing the physician to continue with active venting procedures. In regards a passive venting procedure may not have sufficient mitigation to allow the physician to identify the potential hazard with sufficient time to preclude a potential for injury. Therefore, passive users will be instructed not to use the system until a software improvement is put into place. Additionally, no catheters or consoles will be shipped to passive venting users of truFreeze. A response form to be signed and returned confirming receipt of the notification.Questions contact: Stephen Mascioli, MD 781-538-4755 [email protected].

Root Cause

Software design

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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