Argyle 8888256529Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884527006410), received between Apr 29, 2020 and May 29, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE REPLOGLE TUBE WAS CUT IN HALF IN PACKAGING. UPON INSPECTION OF OTHER REPLOGLE TUBES IN THE UNIT, ANOTHER PACKAGING HAD A CUT PIECE OF REPLOGLE TUBE ATTACHED TO IT. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109072 ↗
• MalfunctionJan 16, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THEY THINK THE END OF THE REPLOGLE HAS SNAPPED OFF INSIDE THE OESOPHAGEAL POUCH OF A BABY OR WAS NOT PRESENT BEFORE PLACING INTO THE BABY. STAFF REMOVED THE REPLOGLE TUBE, SIZE 8FR, ON 12JAN2025, FROM THE BABY AND NOTED THAT THE TIP WAS MISSING. IT HAD A JAGGED END LIKE IT HAD SNAPPED OFF. THE BABY HAS HAD A NUMBER OF X-RAYS BUT NO OBVIOUS TIP WAS REMAINING IN THE OESOPHAGEAL POUCH. THE FRAGILITY OF THE END PIECE THAT SITS IN PATIENT SHOULD BE LOOKED AT AS IT DOESN¿T LOOK AS SOLID AS IT USED TO (HENCE WHY IT HAS SNAPPED OFF).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169659 ↗
• MalfunctionJul 5, 2022Difficult to Flush; Difficult to Flush

  CUSTOMER REPORTS: A NEW REPLOGLE WAS REQUIRED AND DISLODGED WITH EXTUBATION AND FELL ONTO THE BED. THE DEVICE COULD NOT BE FLUSHED WITH SALINE OR AIR; RESISTANCE WAS FELT. A SECOND NEW REPLOGLE TUBE WAS OBTAINED AND CHECKED TO SEE IF IT WOULD FLUSH PRIOR TO INSERTION. THE PRODUCT WOULD FLUSH BUT THERE WAS INCREASED RESISTANCE, POSSIBLY A NARROWING INSIDE THE INLET PORT. THE INLET PORT APPEARED TO BE CLOSED FURTHER ALONG THE DEVICE. A THIRD DEVICE WAS OBTAINED AND CHECKED PRIOR TO INSERTION AND THERE WERE NO ISSUES THEREFORE THE DEVICE WAS USED. THERE WAS NO HARM TO PATIENT AT THIS TIME. THE THREE DEVICES WERE FROM THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14919109 ↗
• InjuryApr 7, 2022Break; Break

  THE CUSTOMER REPORTED ON (B)(6) 2021 A BABY WAS OPERATED ON FOR ATRESIA, CAME OUT WITH A LEVINE (NASOGASTRIC TUBE) IN PLACE, CLAMPED AND REMOVED FOR INSTALLATION OF A REPLOGLE #8, FIXED AT 20 CM AT 11 P.M. A LUNG X-RAY WAS DONE. ON (B)(6) 2021: THE BABY SHOWED THIN RED BLOOD IN THE NASOGASTRIC TUBE (NGT) BAG. BILIOUS FLUID MIXED WITH BLOOD THAT DRAINED 110ML IN 35MIN. AN X-RAY OF THE ABDOMEN WAS DONE WHICH SHOWS A STRUCTURE COMPARABLE TO THE NGT BUT WHICH IS NOT SEEN LATERALLY WHICH COULD MATCH A COMPOSITION IMAGE WITH A TUBING ON THE PATIENT'S SKIN. THE BABY WAS TRANSFERRED TO INTENSIVE CARE. THE BABY VOMITED FRESH BLOOD WITH A BILIOUS MIXTURE. AT 11:40 P.M., THE BABY TRANSFERRED TO THE OPERATING ROOM. ON (B)(6) 2021: AT 4:32 A.M., THE BABY RETURNED FROM THE OPERATING ROOM, THE REPLOGLE WAS IN PLACE FIXED AT 15 CM. AT 7:00 A.M.: 6 ML OF BLOOD WAS DRAINED BY THE REPLOGLE. ON (B)(6) 2021: A LATERAL AP SHOWED PRESENCE OF A LINEAR STRUCTURE LOCATED IN THE CENTER OF THE ABDOMEN THAT WAS PRESENT ON THE FILMS OF (B)(6), WHICH DOES NOT APPEAR TO BE ON THE SKIN. ON (B)(6) 2021: PER OS RESTARTED AT 10 A.M. (REPLOGLE REMOVED). NO NASOGASTRIC TUBE (NGT), ONLY FEEDING BOTTLES ARE GIVEN TO THE

  Patient problems: Foreign Body In Patient

  MAUDE report 14042646 ↗
• MalfunctionOct 7, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE PRODUCT FOUND TO BE IN EDGE OF SEALED PACKAGE AND HAS BEEN CUT APART. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PRODUCT WAS CUT COMPLETELY, THE SEPARATE PIECE WAS STUCK IN THE SEAL ON THE EDGE OF THE PACKAGING. THE ISSUE WAS DISCOVERED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590448 ↗
• MalfunctionSep 22, 2021Break; Suction Failure; Break; Suction Failure

  ADDITIONAL INFORMATION RECEIVED OCT. 12, 2021: THE RN AT THE FACILITY CUT THE TUBE TO MAKE THE HOLE LARGER SO THE FRACTURED PIECE OF THE CATHETER WAS INTENTIONAL AND NOT A BREAK. THE RN WAS UNABLE TO GET THE REPOLGLE TO SUCTION/DECOMPRESS SO CUT ONE OF THE HOLES LARGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512386 ↗
• MalfunctionApr 29, 2020Restricted Flow rate; Restricted Flow rate

  THE CUSTOMER REPORTED AN INFANT HAD A REPLOGLE TO SUCTION PLACED. SINCE INSERTION, THERE WAS NO OUTPUT AND INCREASED ABDOMINAL DISTENTION. A DECISION WAS MADE TO REMOVE THE TUBE AND REPLACE IT. THE HOLES AT THE BOTTOM OF THE SUCTION CATHETER THAT WAS REMOVED APPEARED TO BE SMALL. AFTER THE NEW TUBE WAS INSERTED AND PLACED TO SUCTION, THE INFANT HAD INCREASED OUTPUT AND THE ABDOMINAL DISTENTION REDUCED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Abdominal Distention

  MAUDE report 10009833 ↗