Wallach 900161Recalls & reported problems
Coopersurgical, Inc. · LL-CO2 Multi-Tip Cryosurgical System (Pinned Yoke-CGA 940) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937009804), received between Jun 16, 2021 and Jun 17, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
3 other recalls cover devices cleared under the same FDA submission (K803311); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash2
- Break1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2021Leak/Splash
PER CUSTOMER: LEAKING FROM HOUSING/HANDPIECE. PER REPAIR TECH: NO DEFECTS FOUND. TESTED OK. REPAIR LOG: (B)(4). LL-CO2 CRYOSURGICAL SYS 900161. E-COMPLAINT- (B)(4).
Patient problems: Insufficient Information
MAUDE report 12017603 ↗MalfunctionJun 16, 2021Break; Leak/Splash
PER CUSTOMER: LEAKING FROM THE HOUSING/HANDPIECE. PER TECH: CONFIRMED: LEAKING AT DAMAGED ENDCAP INSULATOR. REPAIR LOG: (B)(4). LL-CO2 CRYOSURGICAL SYS 900161 (B)(4).
Patient problems: Insufficient Information
MAUDE report 12011296 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K803311. One submission often covers many models, so check the product and lot details in each record.
- Z-1450-2015 · Mar 9, 2015 · TerminatedWALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2
- Z-1046-2007 · Jun 6, 2007 · TerminatedWallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
- Z-1045-2007 · Jun 6, 2007 · TerminatedWallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218
Other Unit, Cryosurgical, Accessories devices
- IceFORCE® 2.1 CX 90° Cryoablation Needle FPRPR3602Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls4 deaths274 reports
- IceRod® 1.5 CX 90° Cryoablation Needle FPRPR3533Boston Scientific Corporation · Unit, Cryosurgical, Accessories1 recall168 reports
- IcePearl® 2.1 CX 90° Cryoablation Needle FPRPR3601Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls78 reports
- IceFORCE™ 2.1 CX L 90° Cryoablation Needle FPRPR3618Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls6 reports
- IceFORCE® 2.1 CX Cryoablation Needle FPRPR3604Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls3 reports
- IcePearl™ 2.1 CX L 90° Cryoablation Needle FPRPR3617Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls1 report
- IcePearl® 2.1 CX Prostate Cryoablation Kit / Visual-ICE® System FPRPR3606Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls0 reports
- IceFORCE® 2.1 CX Prostate Cryoablation Kit / Visual-ICE® System FPRPR3605Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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