Orthos 219-4108Recalls & reported problems
Ormco Corporation · ORTHOS CM CUNITI 35ARCH 16X22LOSMPK10 · Class 1
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 00889989030587), received between May 5, 2023 and Jun 2, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT THE PICC LINE CATHETER FOR CENTRAL VENOUS USE WAS USED TO DELIVER CYTOTOXIC SUBSTANCES. PATIENT GIVEN PICCLINE ON (B)(6) 2023, LAID ON 4 CM, PRIOR TO CHEMOTHERAPY TREATMENT- CISPLATIN AND WITH PREHYDRATION WHICH IS FINE TO GIVE. PATIENT IS WITH HIS DOCTOR IN THE WARD 2023-05-03- WHO SEES AFTER REARRANGEMENT OF PICCLINE- WHEN FLUSHING THAT IT LEAKS. SODIUM CHLORIDE IN THE NEWLY APPLIED DRESSING. THE PATIENT IS ASKED TO CONTACT US. PATIENT CALLS AND ARRIVES - NURSE REMOVES DRESSING - PUTS COMPRESS UNDER INJECTION SITE AND SECURA CATH - SEES LEAKAGE. PICCLINE NURSE IS CALLED - THE LID OF THE SECURACATH IS LIFTED OFF - THE PICCLINE NURSE PULLS OUT THE PICCLINE A LITTLE AT A TIME - AFTER 1.5 CM A HOLE CAN BE SEEN ON THE CATHETER - I.E. AT 5.5 CM. A NEW CATHETER NEEDS TO BE INSERTED. NEW ACCESS NEEDED, EXTENDED WAITING TIME. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17055864 ↗MalfunctionMay 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT IS USING THE PICC FOR UNKNOWN CHEMO. NOW THE CATHETER IS LEAKING, AND THEY PULLED IT OUT. ADDITIONAL INFORMATION RECEIVED APRIL 22 2023: IT WAS REPORTED BY THE CUSTOMER "THE PATIENT WAS NOT HARMED BUT NEEDED A NEW PICC." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16882447 ↗
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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