Approach G50788Recalls & reported problems
Cook Incorporated · Approach, CTO-18 Micro Wire Guide · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002507883), received between Jan 17, 2025 and Jan 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
2 FDA recall records name this device's identifier, 2 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.
Reports received per month
Recalls naming this device
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1777-2026 · Root cause: Incorrect or no expiration date · FDA record ↗
- Oct 8, 2024Open, Classified
Affected device lots have labels that state the incorrect expiration dates.
Z-0346-2025 · Root cause: Labeling Change Control · FDA record ↗
Most reported problems
Device problems
- Break1
- Flaked1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2025Break; Flaked; Break; Flaked
AS REPORTED, DURING A BELOW-THE-KNEE ANGIOPLASTY PROCEDURE INVOLVING THE RIGHT POSTERIOR TIBIAL ARTERY (PTA), THE TIP OF AN APPROACH TO MICROWIRE WIRE GUIDE SEPARATED UPON REMOVAL OF THE DEVICE. ANTEGRADE ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY WITH AN UNKNOWN 4-FRENCH, 11-CENTIMETER SHEATH TO TARGET THE POSTERIOR TIBIAL ARTERY. A DIAGNOSTIC ANGIOGRAM WAS PERFORMED DURING THE PROCEDURE, AS WELL AS ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY. THE POSTERIOR TIBIAL ARTERY WAS OCCLUDED AND SEVERELY CALCIFIED, WITHOUT SIGNIFICANT TORTUOSITY. THE WIRE WAS NOT ALTERED PRIOR TO USE. RESISTANCE WAS NOT ENCOUNTERED WHEN THE WIRE WAS INSERTED INTO ANOTHER MANUFACTURER¿S CATHETER; HOWEVER, RESISTANCE WAS REPORTEDLY ENCOUNTERED ¿DURING WIRE DRILLING¿ INTO THE CALCIFIED SEGMENT OF THE VESSEL. THE WIRE BECAME STUCK IN THE CATHETER, WITHIN THE OCCLUDED PTA SEGMENT. THE TIP OF THE WIRE SEPARATED AND UNRAVELED AND REMAINS IN THE OCCLUDED SEGMENT OF THE MID- POSTERIOR TIBIAL ARTERY. THE WIRE WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT DURING THE PROCEDURE. REPORTEDLY, THE CUSTOMER DOES NOT SUSPECT A MALFUNCTION OF THE WIRE, AS IT BROKE OFF DUE TO A
Patient problems: Foreign Body In Patient
MAUDE report 21183972 ↗
Other Catheter for crossing total occlusions devices
- Crosser iQ XCTO146Bard Peripheral Vascular, Inc. · Catheter for crossing total occlusions157 reports
- Approach G50791Cook Incorporated · Catheter for crossing total occlusions2 recalls15 reports
- Approach G50792Cook Incorporated · Catheter for crossing total occlusions2 recalls7 reports
- Approach G50787Cook Incorporated · Catheter for crossing total occlusions2 recalls2 reports
- Approach G50786Cook Incorporated · Catheter for crossing total occlusions2 recalls1 report
- Approach G50789Cook Incorporated · Catheter for crossing total occlusions2 recalls0 reports
- OUTBACK OTB59120ACordis US Corp. · Catheter for crossing total occlusions82 reports
- Approach G50793Cook Incorporated · Catheter for crossing total occlusions1 recall17 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.