Z-1513-2015Class II

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

Name: Z-1513-2015 CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
Creator: CSA Medical
Published: 2015-03-25
License: https://open.fda.gov/license/

CSA Medical / initiated 2015-03-25 / Terminated / root cause: software

FDA source

CSA Medical began a recall of CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01 on 2015-03-25. FDA classified it as Class II and gives the reason as "TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1513-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-25
Posted: 2015-04-23
Terminated: 2015-08-21
Recalling firm: CSA Medical
Product: CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax
Root cause tag: software
FDA 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 [email protected].
Quantity in commerce: 82 units
Distribution: Nationwide
Product codes and lots: Serial Numbers: 01-00106 through 01-00201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1513-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1513-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-23

Product code GEH

K143625Class IItruFreeze SystemCSA Medical, Inc. / cleared 2015-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)