CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
FDA device recall Z-1513-2015 · posted 2015-04-23 · Terminated
Recall details
- Recalling firm
- CSA Medical
- Reason for recall
- TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax
- Action taken
- 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 smascioli@csamedical.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GEH
- Quantity affected
- 82 units
- Distribution
- Nationwide
- Date initiated
- 2015-03-25
- Date posted
- 2015-04-23
- Date terminated
- 2015-08-21
- Location
- Lexington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| truFreeze System (K143625) | CSA Medical, Inc. | 2015-01-15 |