REPEATERRecalls & reported problems across all models
Baxter Healthcare Corporation · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 189
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 6 models of REPEATER by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 189 adverse event reports in the FDA's MAUDE database, received between Jan 22, 2018 and Sep 29, 2026 — classified as 189 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (95 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported REPEATER problems
Device problems
- Fluid/Blood Leak95
- Disconnection39
- Device Contamination with Chemical or Other Material38
- Break19
- Air/Gas in Device10
- Detachment of Device or Device Component5
- Loose or Intermittent Connection5
- Material Split, Cut or Torn3
Patient problems
- No Clinical Signs, Symptoms or Conditions131
- No Patient Involvement54
- No Consequences Or Impact To Patient4
REPEATER models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- REPEATER H93811Set, i.V. Fluid transfer165 reports
- REPEATER H93821Set, i.V. Fluid transfer19 reports
- REPEATER H93829Set, i.V. Fluid transfer2 reports
- REPEATER H938331Set, i.V. Fluid transfer1 report
- REPEATER H938099EGSystem/device, pharmacy compounding1 report
- REPEATER H938099RGSystem/device, pharmacy compounding1 report
Recent REPEATER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934444 ↗MalfunctionSep 17, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808665 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781697 ↗MalfunctionSep 13, 2026Fluid/Blood Leak; No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747677 ↗MalfunctionAug 12, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229246 ↗MalfunctionJun 5, 2026Fluid/Blood Leak
IT WAS REPORTED THAT NINE (9) STERILE REPEATER PUMP TUBE SETS LEAKED AT THE CONNECTION POINT BETWEEN THE TUBING AND THE PUMP CONNECTORS (BLUE PLASTIC PIECE). THIS OCCURRED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25407664 ↗MalfunctionApr 30, 2026Air/Gas in Device
IT WAS REPORTED THAT AIR WAS LEAKING INTO THE LINES OF A STERILE REPEATER PUMP TUBE SET. DURING COMPOUNDING, LARGE AIR BUBBLES WERE OBSERVED IN A COUPLE OF THE NON BAXTER UNITS WHILE BEING FILLED WITH NORMAL SALINE. AFTER CHANGING THE SET, THEY DID NOT EXPERIENCE THIS ISSUE AGAIN. THIS ISSUE WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25052508 ↗MalfunctionApr 20, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) STERILE REPEATER PUMP TUBE SETS LEAKED. THE LOCATION OF THE LEAK WAS DESCRIBED AS "THE BACK END ON THE IV BAG SIDE WHERE THE TUBING ENTERS INTO THE REPEATER PUMP." THIS ISSUE WAS IDENTIFIED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933774 ↗MalfunctionApr 14, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET LEAKED NORMAL SALINE (NS) DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24880093 ↗MalfunctionMar 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET HAD A SMALL LEAK BETWEEN THE CLAMP AND TUBING. THE ISSUE WAS IDENTIFIED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24576355 ↗MalfunctionMar 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SETS LEAKED DRUG IN THE "FLOW RATE CONTROL CLAMP". THE ISSUE WAS NOTICED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567988 ↗MalfunctionMar 6, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) STERILE REPEATER PUMP TUBE SETS LEAKED AT THE JUNCTION. THIS WAS OBSERVED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532533 ↗MalfunctionMar 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) STERILE REPEATER PUMP TUBE SETS LEAKED BETWEEN THE CLAMP AND TUBING. THIS WAS OBSERVED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497431 ↗MalfunctionMar 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A STERILE REPEATER PUMP TUBE SET LEAKED BETWEEN THE CLAMP (PUMP CONNECTORS) AND THE TUBING. THIS OCCURRED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489984 ↗MalfunctionFeb 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THREE (3) STERILE REPEATER PUMP TUBE SETS LEAKED BETWEEN THE CLAMP (PUMP CONNECTORS) AND THE TUBING. ONE ISSUE OCCURRED DURING COMPOUNDING, WHILE TWO OCCURRED DURING TESTING OF THE AFFECTED BATCH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471981 ↗
Other Baxter Healthcare Corporation products
- EXACTAMIX28 models · 6,739 reports · 13 recalls
- MiniCap3 models · 3,423 reports · 7 recalls
- Novum IQ3 models · 1,540 reports · 7 recalls
- CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
- CLEARLINK19 models · 710 reports · 4 recalls
- CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
- CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
- DUO-VENT5 models · 31 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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