N/A (REF 072402)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Steerable Diagnostic EP Catheter, 55-75MM, MCXL (MARINR), 4 electrodes, 2-5-2mm spacing, 7F · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Apr 10, 2026Open, Classified
Incomplete seals on sterile product
Z-2199-2026 · Root cause: Process control · FDA record ↗
Other CATHETER, RECORDING, ELECTRODE, REPROCESSED devices
- MEDLINE 401904RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed3 recalls1 report
- MEDLINE 401582RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed3 recalls0 reports
- MEDLINE 401474RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls1 report
- MEDLINE 81102RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE BD710FJ282RRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE BD710DF282RRHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 401448RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 401222RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.