Palindrome 8888145057Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521013315), received between Jul 23, 2019 and Oct 23, 2023 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

64 other recalls cover devices cleared under the same FDA submission (K112477); 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.

Recalls naming this device

1. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1319-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2023Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A BLUNT TIP AND DID NOT PROGRESS THROUGH THE DILATOR AND THE PATIENT'S STRUCTURES. IT WAS ALSO STATED THAT IT BENT MORE EASILY AND WORSENED THE BLOOD FLOW. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17988131 ↗
• InjuryJan 26, 2022Naturally Worn; Naturally Worn

  ACCORDING TO THE REPORTER, DURING CATHETER EXCHANGE, THE DOCTOR NOTICED A FEW BLISTERING ON THE SILVER ION SLEEVE. THE PROCEDURE WAS COMPLETED, THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, THERE WAS NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT, THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AN ANTIMICROBIAL DRESSING WAS USED. THE PATIENT WAS TREATED FOR (B)(6) BACTEREMIA AND THE SOURCE WAS EITHER ELBOW BURSITIS OR CRBSI (CATHETER-RELATED BLOODSTREAM INFECTION). IT WAS ALSO STATED THAT ANTIBIOTICS FOR BACTEREMIA AND REMOVAL OF DIALYSIS CATHETER WAS PROVIDE TO THE PATIENT AS THE MEDICAL INTERVENTION. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, CHLORHEXIDINE WAS USED ON THE DEVICE AS THE CLEANING AGENT, TEGO WAS UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Bacterial Infection

  MAUDE report 13357803 ↗
• MalfunctionOct 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE ARTERIAL EXTENSION TUBE WAS DISCONNECTED FROM THE HUB. THE TREATMENT WAS COMPLETED, THERE WAS A BLOOD LOSS OF ROUGHLY 20 ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS PERFORMED WITH SALINE AND GOOD FLOW, AND NO LEAKAGE WAS OBSERVED. THERE WAS NO OTHER PRODUCTS UTILIZED WITH THE DEVICE, THE BLOOD OF THE PATIENT WAS NOT SAFELY RETURNED, BETADINE AND ALCOHOL AFTER DRYING WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT AND THE CLAMPS WERE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE JUNCTION OF THE EXTENSION TUBE AND BIFURCATE. STERI PREP WAS USED AS THE CLEANING AGENT ON THE DEVICE, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE WAS REPLACED AND LOCAL ANALGELSIA (LIGNOCAINE) WAS USED TO RESOLVE THE ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605210 ↗
• MalfunctionMay 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, THE ARTERIAL EXTENSION TUBE OF THE CATHETER GOT DISCONNECTED FROM THE HUB AND SHOWED A CRACK AT THE END/JUNCTION WHERE IT CONNECTED TO THE HUB. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE AND NO OTHER INTERVENTION WAS DONE. NOTHING UNUSUAL WAS OBSERVED PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE AND DEVICE WAS REPORTED TO HAVE GOOD FLOW. IT WAS REPORTED THAT CLAMPS ARE MOVED TO A NEW LOCATION AFTER EACH TREATMENT. NO OTHER PRODUCTS ARE UTILIZED WITH THE DEVICE. THERE WAS A BLOOD LOSS OF 100ML AND NO TRANSFUSION WAS REQUIRED. CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, STERI-PREP WAS THE CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854670 ↗
• MalfunctionApr 19, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, POST INSERTION, THE CATHETER GOT BLOCKED WITH BLOOD CLOTS AND THERE WAS A VESSEL WALL OCCLUSION, SO THERE WAS NO BLOOD FLOW OBSERVED EVEN ON REVERSING THE LINES. THE CATHETER WAS NOT REPAIRED AND HAD NO LEAK. IODINE PROVIDINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 11689069 ↗
• InjuryOct 17, 2019Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, TWO MONTHS AFTER IMPLANTATION, INFECTION WAS NOTICED AT THE EXIT SITE WHILE IN ROUTINE CHECK UP OF DIALYSIS SESSIONS (PATIENT WENT TO THE HOSPITAL TO HAVE THE DEVICE CHECKED). A CULTURE GROWTH YIELDED PSEUDOMONAS SPP AND THE DEVICE HAD TO BE REMOVED. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND POVIDONE IODINE WASH AND ALCOHOL WASH WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. POVIDONE IODINE WAS ALSO USED AS A CLEANING AGENT ON THE DEVICE AND THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE PATIENT WAS GIVEN ORAL ANTIBIOTIC AND THERE WERE NO OTHER MEDICAL INTERVENTION PERFORMED TO TREAT THE INFECTION. THE PATIENT'S DIALYSIS IS ON GOING.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 9203579 ↗
• InjuryOct 11, 2019Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, 2 MONTHS AFTER THE CATHETER WAS INSERTED TO THE PATIENT, THEY FOUND THAT THE SILVER ION SLEEVE REGION AND SHAFT BECAME GRANULAR IN APPEARANCE. IT WAS MENTIONED THAT THE FLOW WAS OKAY BUT THE REGION LOOKED ODD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; Swelling; Unspecified Infection

  MAUDE report 9182309 ↗
• MalfunctionJul 23, 2019Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE DEVICE HAD A LEAK AT THE JUNCTION OF THE EXTENSION TUBE AND BIFURCATE, IT WAS ALSO MENTIONED THAT A CRACK WAS FOUND AT THE LUER ADAPTER. NOTHING UNUSUAL OBSERVED PRIOR TO USE, NO PACKAGING DAMAGE, CATHETER LUMENS FLUSHED, THEY DID NOT TRY TO REVERSE THE LINE AND TEGO WAS NOT UTILIZED, THE RIGHT SIDE OF THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT, NO BLOOD TRANSFUSION DONE. CATHETER WAS REMOVED AND IT WAS REPORTED THAT PATIENT TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818360 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112477. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2022 · Jun 8, 2022 · Open, Classified
  Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1317-2022 · Jun 8, 2022 · Open, Classified
  Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1900-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P
• Z-1857-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
• Z-1858-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062
• Z-1902-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
• Z-1898-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
• Z-1864-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
• Z-1854-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
• Z-1887-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
• Z-1895-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
• Z-1859-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C
• Z-1860-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
• Z-1911-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
• Z-1885-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408P

…and 49 more.