FDA Medical Device Recalls (openFDA)
CSA Medical: CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
- Recall number
- Z-1513-2015
- Recalling firm
- CSA Medical
- Product
- CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
- Status
- Terminated
- Initiated
- 2015-03-25
- Posted
- 2015-04-23
- Terminated
- 2015-08-21
- Reason
- TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax
- Root cause
- Software design
- 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 smascioli@csamedical.com.
- Quantity
- 82 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial Numbers: 01-00106 through 01-00201
- 510(k) numbers
- ["K143625"]
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 3010140265
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28