Deltec 21-4034-24Recalls & reported problems
Icu Medical, Inc. · Class 2 · Implant
All models of Deltec (97)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586023811), received between Apr 24, 2026 and Apr 24, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
1 other recall cover devices cleared under the same FDA submission (K830730); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- Device Embedded In Tissue or Plaque1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2026Migration
A PRODUCT LIABILITY LAWSUIT WAS RECEIVED THROUGH A WATCH SERVICE. THE LAWSUIT ALLEGES THE FOLLOWING: ON OR ABOUT (B)(6) 2005, THE PATIENT¿S DELTEC LOW PROFILE PORT A CATH, ITEM NUMBER 21 4034 24 AND LOT NUMBER M21192, WAS EXPLANTED DUE TO A CATHETER COMPONENT OF THE IMPLANTED PORT HAVING FRACTURED AND EMBOLIZED, MIGRATED THROUGH THE HEART, AND LODGED IN THE LEFT DESCENDING PULMONARY ARTERY. THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ADMINISTERING CHEMOTHERAPY AS TREATMENT FOR BREAST CANCER ON OR ABOUT (B)(6) 2005.
Patient problems: Device Embedded In Tissue or Plaque; Thrombosis/Thrombus
MAUDE report 24983936 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K830730. One submission often covers many models, so check the product and lot details in each record.
- Z-0152-2016 · Sep 14, 2015 · TerminatedPORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal sy
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- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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